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F.D.A. to Check Safety of Old Devices

WASHINGTON — Federal regulators said Wednesday that that they would ask makers of some of the riskiest medical devices to prove that their products were safe and effective — a step that critics have said was long overdue.

In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976.

Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress told the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which ones did not.

The agency never finished that process, leaving 27 different types of devices unexamined — products that include artificial lung membranes, external defibrillators and various pacemaker components.

For decades, the F.D.A. has approved devices in these categories for sale without demanding rigorous tests showing that they work safely. Investigators for the accountability office stated that “it is imperative that F.D.A. take immediate steps” to fix its system for approving such devices, and the agency agreed.

The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness.

Mary Long, an F.D.A. spokeswoman, said she could not predict how long the reclassification process for the older devices would take.

“We have to review each device type separately,” she said. “It will take some time.”

Industry groups predict that the F.D.A. will conclude that most of the products are not risky enough to warrant greater scrutiny. “The device types subject to the F.D.A. notice have already been thoroughly reviewed by the agency,” said Janet Trunzo, executive vice president of the Advanced Medical Technology Association.

“It’s great that F.D.A. is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness,” said Diana Zuckerman, president of the National Research Center for Women and Families.

A version of this article appears in print on , on page B12 of the National edition with the headline: F.D.A. to Check Safety of Old Devices. Order Reprints|Today's Paper|Subscribe